KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)— 510(k) K973507

Clearance details

Applicant

Kendall Healthcare Products Co. Div.Of Tyco Health

Product code

Code FRO

Device class

Unclassified

Advisory panel

Unknown

Date received

1997-09-16

Decision date

1997-12-15

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Mansfield, MA, US

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• K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
• K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
• K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
• K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04
• K973546 — KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER1997-11-07

Death

30

Injury

653

Malfunction

479

Other

11

Total

1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →